Product Validation Consultant

2 weeks ago

Cork, Cork, Ireland beBeeValidation Full time €60,000 - €80,000

Validation Specialist

We are seeking a skilled validation specialist to fill this key role in our team. This position is based in Waterford, working with a pharmaceutical client.

About the Role:

  • Develop and execute process validation protocols for equipment, systems, and processes.
  • Implement quality assurance strategies to ensure compliance with US FDA and EU regulations.
  • Provide technical guidance on current regulations and industry best practices for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
  • Maintain accurate documentation throughout the validation lifecycle.
  • Participate in external audits and support Site Change Control process.
  • Troubleshoot validation issues associated with projects and process development.

Requirements:

  • Degree in Science or Engineering.
  • Previous experience in validation/product development is highly advantageous.
  • Familiarity with Process Validation regulations, industry practices, and guidelines.
  • Knowledge of GAMP, ISPE Baseline guides, AAMI/ANSI, PDA, and ISO guidelines.
  • Understanding of quality and compliance regulations.
  • Ability to manage projects effectively.
  • Strong knowledge of quality management systems.
  • Excellent communication skills.

Why Choose Us:

We offer a dynamic work environment, opportunities for growth and professional development, and a commitment to excellence in all aspects of our business.

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